Pregnancy outcome following first-trimester exposure to fingolimod: A collaborative ENTIS study

Emmanuelle Pauliat; Marlies Onken; Corinna Weber-Schoendorfer; Valentin Rousson; Marie-Claude Addor; David Baud; Marie Théaudin; Orna Diav-Citrin; Judith Cottin; Antonia Agusti; Victoria Rollason; Yusuf C Kaplan; Debra Kennedy; Mine Kadioglu; Laura E Rothuizen; Françoise Livio; Thierry Buclin; Alice Panchaud; Ursula Winterfeld

doi:10.1177/1352458520929628

Pregnancy outcome following first-trimester exposure to fingolimod: A collaborative ENTIS study

Mult Scler. 2021 Mar;27(3):475-478. doi: 10.1177/1352458520929628. Epub 2020 Jun 15.

Authors

Emmanuelle Pauliat¹, Marlies Onken², Corinna Weber-Schoendorfer², Valentin Rousson³, Marie-Claude Addor⁴, David Baud⁵, Marie Théaudin⁶, Orna Diav-Citrin⁷, Judith Cottin⁸, Antonia Agusti⁹, Victoria Rollason¹⁰, Yusuf C Kaplan¹¹, Debra Kennedy¹², Mine Kadioglu¹³, Laura E Rothuizen¹, Françoise Livio¹, Thierry Buclin¹, Alice Panchaud¹⁴, Ursula Winterfeld¹

Affiliations

¹ Swiss Teratogen Information Service, Service de Pharmacologie Clinique, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
² Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Pharmakovigilanzzentrum Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Berlin, Germany.
³ Center for Primary Care and Public Health, University of Lausanne, Lausanne, Switzerland.
⁴ Department of Woman-Mother-Child, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
⁵ Materno-Fetal and Obstetrics Research Unit, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
⁶ Department of Clinical Neurosciences, Division of Neurology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
⁷ The Israeli Teratology Information Service, Ministry of Health, Jerusalem, Israel/The Hebrew University Hadassah Medical School, Jerusalem, Israel.
⁸ Centre Régional de Pharmacovigilance, Hospices Civils de Lyon, Lyon, France.
⁹ Clinical Pharmacology Service, Vall d'Hebron University Hospital, Barcelona, Spain.
¹⁰ Division of Clinical Pharmacology and Toxicology, Geneva University Hospitals, Geneva, Switzerland.
¹¹ Terafar - Izmir Katip Celebi University Teratology Information, Research and Training Center, Izmir, Turkey.
¹² Mothersafe, The Royal Hospital for Women, Sydney, NSW, Australia/School of Women's and Children's Health, University of New South Wales, Sydney, NSW, Australia.
¹³ Department of Pharmacology, Faculty of Medicine, Karadeniz Technical University, Trabzon, Turkey.
¹⁴ School of Pharmaceutical Sciences, University of Geneva and University of Lausanne, Geneva, Switzerland.

PMID: 32538681
DOI: 10.1177/1352458520929628

Abstract

This prospective multicentre cohort study investigated pregnancy outcomes after fingolimod use for multiple sclerosis during pregnancy. Pregnancy outcomes of 63 fingolimod and 62 interferon-β-exposed pregnancies were compared. Rates of major congenital anomalies (MCA) were 4.8% (2/42) in the fingolimod group versus 2.3% (1/44) in the interferon-β group (odds ratio, 2.2; 95% confidence interval, 0.2-24.6). The adjusted hazard ratio for spontaneous abortion in fingolimod versus interferon-β-exposed pregnancies was 0.6 (95% confidence interval, 0.2-1.8). Further studies are needed to definitely rule out a moderately increased MCA risk after fingolimod exposure during pregnancy.

Keywords: Fingolimod; birth defect; cohort study; interferon; multiple sclerosis; pregnancy.

MeSH terms

Cohort Studies
Female
Fingolimod Hydrochloride* / adverse effects
Humans
Pregnancy
Pregnancy Outcome*
Pregnancy Trimester, First
Prospective Studies

Substances

Fingolimod Hydrochloride